中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

1-3 September 2021 | SWEECC H2&H4

The Printed World: Additive Manufacturing in Medtech

2021-01-22

The COVID-19 pandemic continues to create logistical challenges due to disruptions in manufacturing and transportation, along with resistance against globalization and free trade. This has curtailed the global supply chain, provoking critical shortages of essential goods. There is a desperate need for factories to manufacture on-demand materials and devices for a range of essential healthcare services.

A robust and resilient manufacturing network fueled by a distribution of additive manufacturing (3D printing) factories can help mitigate the shortage of necessary products. Critical parts can be made on-demand by a decentralized 3D printing facility by leveraging shared designs, some of which might require customization or complex designs. The applications are manifold: medical devices (ventilator valves, CPAP mask connectors), personal protective equipment (face shields, respirators, filters), testing devices, and personal accessories (face masks, mask fitters/adjusters).

For example, CPAP machines are being used as substitutes for ventilator machines for COVID-19 patients requiring therapy owing to their shortage. Italian engineering firm Isinnova devised a 3D-printable mask connector design intended to fit and connect Decathlon’s Easybreath snorkeling masks to CPAP machines. 3D printing is also an efficient manufacturing method to meet the demand for nasopharyngeal swabs used in COVID-19 diagnostic testing. The 3D printed swabs can be made with complex tip structures that boost sample collection efficiency, removing the need to apply flocks at the tips.

3D printing’s mass customization capability also enable personalized face masks with an ergonomic fit, by marrying 3D printing with 3D scanning of the wearer’s face. 3D printing can also address environmental concerns for medical waste accumulated from disposable PPE. It offers solutions to conserve resources by encouraging recyclable materials and reusability of respirators and filters.

In the heat of the pandemic, additive manufacturing has become a crucial technology to support improved healthcare and response to the pandemic. Its inherent flexibility and ability to modify designs available online are unveiling creative and sustainable solutions that can propel the technology forward post-pandemic. As the global economy reopens, supply chains are forecasted to become shorter and more fragmented, resulting in different manufacturing procedures with more collaborations in an open additive manufacturing relationship. Thanks to 3D printing’s potential for a high level of customization and decentralized manufacturing, local ecosystems of 3D printing factories are likely to emerge. Further, digitization will keep transforming 3D printing machines into integral parts of the IoT and Industry 4.0 landscapes post-pandemic.

To gain more insight on the trends and challenges impacting the medical additive manufacturing market both during and beyond the pandemic, MPO spoke with five experts in medical additive manufacturing:

Shon Anderson, CEO of B9Creations, a Rapid City, S.D.-based global provider of professional 3D printing solutions.

Geoffrey Doyle, director of business development at Jabil, a St. Petersburg, Fla.-based global manufacturing solutions provider.

Benjamin Johnson, director of product development, healthcare, at 3D Systems, a Rock Hill, S.C.-based additive manufacturing solutions company.

Brian McLaughlin, president and CEO of Amplify Additive, a Scarborough, Maine-based additive manufacturing company specializing in design, engineering, and manufacturing of 3D metal-printed orthopedic implants.

Francesco Robotti, technology business development manager at Lincotek Medical, an Italy-based global provider of medical 3D printing, additive manufacturing, surface treatments, plasma spray, machining, physical vapor deposition, and anodization.

Sam Brusco: In your experience, which areas of medical manufacturing are seeing the most utilization of additive manufacturing?

Traditionally in the medical device industry, we have seen significant utilization of additive manufacturing early on in a product’s lifecycle in the R&D and product design phases. Increasingly, however, we see companies seeking to partner with us to understand how, where, and when to utilize additive manufacturing across the value chain via hybrid manufacturing, bridge production, in manufacturing aids, and more, as well as across a product’s lifecycle via spare parts or end-of-life part production.

As organizations weather historic supply chain disruptions this year, we’re also seeing increasing use of on-site additive manufacturing as a means to onshore manufacturing, build supply chain resiliency, and as an alternative production method for inventory that is rarely used but is costly, requires high minimum order quantities, or comes with long lead times.

On the clinical side, clinics, hospitals, and practitioners are leveraging additive manufacturing for education and training, surgical planning, and patient-customized parts—from custom finger splints for pediatric patients to patient-specific anatomical models and surgical cutting guides—to deliver better patient outcomes.

Geoffrey Doyle: Today’s medical additive manufacturing (AM) includes metal implants, customized surgical aids like surgical guides, and to a lesser degree, patient-specific implants (PSI). PSI are manufactured to a lesser degree due extensive consultative engineering requirements, which leads to high costs. Beyond medical devices, polymer AM is also being used to a lesser extent for a variety of medical equipment and drug delivery systems. We’re also starting to see inroads into prescribed orthotics and prosthetics.

Benjamin Johnson: AM is most widely used in two manufacturing streams. First, it is an essential part of the fabrication of any patient-matched medical device. Hearing aids, orthodontic aligners, and surgical instruments that use patient data to inform the design are typically manufactured using 3D printing technology somewhere in the process. A second adoption of AM technologies is in production of orthopedic implants with osteoconductive surfaces. This is especially true for titanium spine interbody devices that are produced more cost-effectively using 3D printing, with great clinical results.

Brian McLaughlin: When I think of AM and medical, I immediately think of orthopedics because of the application of lattice structures for bone ingrowth. For applications in ortho we print titanium implants for spine, total joints (kips, knees, shoulders), CMF, and oncology. However, I also think there are tremendous applications for AM for surgical instruments. These are a difficult area for the entire industry because of low volume high complexity, which is essentially a perfect fit for AM where we get complexity for free.

Francesco Robotti: Lincotek Medical is pretty focused on orthopedics and our experience using AM is mainly for metal implant construction. Applications range from components intended for large joint reconstruction, to parts intended for shoulder or other extremities repair. We fully exploit the technology also to manufacture interbody fusion cages in the spine segment. While we mainly manufacture implants, another AM business we have is manufacturing of specific and complex shaped metal surgical instruments. We have seen an increase in the demand/requests for lighter weight instrument design and fabrication as well.

Brusco: What new additive manufacturing and supporting technologies has your company most recently invested in? What capabilities do they allow?

Anderson: Developing AM capability requires improvement in at least one of the three pillars of AM performance. This year, we have released major innovations in all three areas, designed to help our customers achieve success.

Historically in the AM space, users were required to choose between accuracy and surface finish. Our patent-pending FAST Technology powered by B9Create 2.0 Pioneer Edition software offers both pinpoint accuracy and smooth surface finish, delivering <15 to <25 micron resolution on all our 3D printer platforms.

B9Create 2.0 Pioneer Edition print preparation, management, and monitoring software also offers a dual platform, equipped with Design Mode’s powerful functionality for experienced users with a range of customization options, as well as Workflow Mode’s step-by-step framework for users new to AM. The software comes with tools to streamline users’ workflows, like support mirroring and part templates, wherein users can orient and support a part once, save the template, then reapply the same orientation and supports to newly imported parts—a significant time savings as medical device manufacturers design and deliver rapid product iterations.

We have also just launched our largest-format printer yet, the B9 Core 5 Series XL and medically equipment compliant B9 Core 5 Series Med XL 3D printers, both powered by FAST Technology. With a 124.8 x 70.2 x 127 mm build envelope, this printer comes equipped with <25 micron effective resolution, a suite of biocompatible and engineering resins, and automated post-processing cleaning and curing units—all in a field deployable platform requiring no special ventilation or power source to enable on-demand production anywhere. For the first time, customers can also choose between a 405 nm and 385 nm light engine.

Finally, we have launched two new materials driven by customer feedback, including a 10993 biocompatible micro precision resin and a silicone-like elastomeric resin, with high detail and rapid response time.

Doyle: Powder bed fusion (PBF) allows us to manufacture porous titanium complex scaffolds for better device osseointegration. Equally as important, we provide secondary processes such as de-powdering, machining, deburring, and polishing so all manufacturing processes are under a single roof. When added to our sterile pack and Gamma sterilization capability, this provides a complete turnkey solution for our regulated healthcare customers.

Johnson: We continue to work with our partners to deliver medical device solutions that improve patient care through medical education, surgical planning, surgical instrumentation, and implants. Most recently, our team released several materials for our Figure 4 platform designed for medical device production and quick turnaround. These innovations allow printing of patient-specific models and surgical instruments in a fraction of the time it used to take, allowing us to address new markets and applications.

McLaughlin: We are very focused on electron beam melting (EBM) technology due to the enhanced bone ingrowth you get with structures built via EBM. There are also inherent advantages to the technology due to the process occurring under a vacuum at elevated temperatures, resulting in superior material properties as compared to other PBF technologies. We will continue to invest in this area and potentially move to develop some new materials on the EBM platform for use in ortho.

As for supporting technologies, we have been very focused on building out our inspection capability. As you can imagine, most of what we print for implants have very few flat surfaces. Therefore, having a good understanding of how to measure is very important. In addition to this and very related, we have added a Markforged 3D Onyx printer to print fixtures for measuring parts. Again, because we design complex parts, we must consider how we inspect those parts. We are using 3D printing in other beneficial ways besides printing implants.

Robotti: While we are constantly working on reducing support structures, we have invested massively in post processing. AM Lincotek Medical lines have been integrated with CNC machining stations to fully support our customers with finished shaped parts delivery.

Our efforts were recently paid with the duplication of the vacuum heat treatment line, essential for metal oxygen/nitrogen sensitive alloys. With massive production running 24/7 to satisfy over 100,000 implants per year, the addition of this state-of-the-art furnace assures us of a validated backup production line with enough flexibility in case a specific heating/cooling recipe has to be applied.

Further, calcium phosphate electrochemical coating was validated for application on AM porous structures. It can coat deep inside the pores’ walls while keeping the porous network pervious. The key advantage for this coating resides in its capability to stimulate bone ingrowth and accelerate the secondary fixation. The same fate was reached for our TiNbN coating, now validated for use on AM implants and on wear surfaces. A typical application is for femoral knee components.

We have invested significantly in a proprietary technology (XClean) able to remove the entrapped powder from inside the porous structure. We can clean up an AM porous implant to a safety level in a validated, fast, and efficient process.

Brusco: Please describe a recent medical additive manufacturing project of note. (Type of part, application area, fabrication process, why it’s noteworthy, etc.)

Anderson: Miniaturization is a macro trend driving the medical device industry. Recently, we worked with a major medical device manufacturer who needed to produce a highly detailed, complex catheter component they were unable to produce with any of their extensive, in-house collection of additive manufacturing technology.

Leveraging our high-resolution B9 Core Series 3D printers, they were able to get all features to resolve on the 2 x 2 x 4 mm representative part. The intricate part boasted two, 8 thousandths of an inch (.2 mm or 200 micron) vertical struts at the top and three holes on the body that were 3 thousandths of an inch (.076 mm or 76 microns) in diameter by 8 thousandths of an inch (.2 mm or 200 microns) deep along a tapered fin measuring 1 thousandth of an inch (.025 mm or 25 microns).

The same medical device manufacturer had an additional project requiring an elastomeric material to print on the highest resolution platform we offer, a unique combination that did not exist in our commercial product portfolio. We worked with them to develop the custom silicone-like material and semi-custom hardware platform capable of <15 micron effective resolution, an entirely customized solution unique to their application and needs.

Doyle: High-volume manufacturing of complex medical implants in material Ti64.

Johnson: Recently, we worked with Stryker’s CMF division to upgrade our portfolio of offerings within our VSP system for surgical guidance of maxillofacial procedures. We now produce osteotomy guides in stereolithography (SLA), selective laser sintering (SLS), and direct metal printing (DMP). The broad palette of material choices allows us to better serve the oral surgeon with more accurate, stronger, and lower profile patient-matched guides. The new guides, compatible with Stryker’s Facial iD line of patient-matched implants, give the surgeon a full ecosystem of customized solutions to improve patient care.

McLaughlin: We are working on a novel extremity product for a client. We have a combination lattice design on this implant design using multiple software tools for different structures in different regions of the implant. Our client came to us needing assistance with doing something that had not been done before, and it was a perfect fit with our capabilities. This is particularly interesting because AM has allowed us to get this product submitted to the FDA in roughly nine months during this COVID time period that has delayed everything.

Robotti: The combination of Brushite coating with an AM porous spinal cage for an overseas customer. The project requires design skills—you keep and balance design needs for the implant device (e.g., structural integrity under loading, surface grip and porous structure for respective primary and secondary fixation, easy positioning, etc.) with the needs of the coating process. The target is to build a sustainable manufacturing process that is up to date regarding innovation and competitive with the current offer.

Brusco: Right now, what’s the largest hurdle medtech additive manufacturing faces to achieve wider adoption?
Anderson: The largest hurdle medtech manufacturing faces to achieve wider adoption is the ability to deliver the right solution across the value chain, from R&D to product design, bridge production, and finally scaled manufacturing. This requires scalable, easy-to-use AM technology, automated post-processing, and a suite of materials that can withstand manufacturing environments. It also entails deep expertise in Lean manufacturing and value stream mapping, systems integration, the regulatory environment, and production. Medtech manufacturers aren’t interested in printers. They’re looking to produce the parts they need with a partner who can deliver.

Doyle: For metal implants, the obstacle comes down to cost per part. On the polymer front, it is material suitability—i.e., materials that can pass the biocompatibility requirement for the given application. Metals are arguably easier on this front, as there are no material substitutions. With traditional metal manufacturing, one uses Ti64 Eli or CoCr, for AM one uses the same chemical composition so there’s no issue of substitution.

Polymers used in medical applications like polycarbonate and PEEK cannot be processed so easily or cost-effectively in an AM process. They also often require material substitutions to materials that can be processed more easily. This creates challenges as medical professionals are risk averse, and rightly so. As a result, it’s difficult enough to change a process, let alone adding a second change through material substitution. FDA regulations make it challenging for fast changes on materials; however, process changes to the same material outcome (mechanical and other properties) is easier through a 510(k).

Johnson: I think there are several hurdles for 3D printing in the medical manufacturing space currently being addressed. First, guidance and standards for validation of additive manufacturing processes are needed to make adoption easier. Fortunately, there are a few standards organizations focused on providing this guidance and we are starting to see the fruits of these efforts. Second, for patient-matched devices, the reimbursement landscape isn’t yet well-established. More clinical data must be generated to show the value of pre-surgical planning, customized instruments, and patient-matched implants that justify specific payment codes for these devices.

McLaughlin: Education of the technology and overall lack of investment. This technology takes time and with experienced hands will change the industry for good, and permanently. There are not enough companies investing in the technology, investing in hiring the right teams, or thinking about the next generation of implants that will be 10 times better than what is currently on the market. Taking total hips as an example, where there are hundreds of thousands implanted in the U.S., AM is a perfect fit for the acetabular cup. Surgeons prefer the AM designs because of initial fixation and overall bone ingrowth, but there are simply not enough suppliers to print nearly a fraction of the industry’s need. Because of that, the industry continues to fall back to more traditional TPS and HA coatings. Those technologies have proved effective over time, but AM structures on cups are an order of magnitude better.

Robotti: Regulatory remains a strong hurdle for new device introduction—especially in Europe with full MDR adoption in the middle of 2021. Beyond Europe, in China there is still a lack of clear regulation for AM parts. Often the OEMs are requested to perform clinical trials and this discourages innovation and new tech adoption.

Still, however, the real limitations for larger AM adoption remains the cost. Legacy technologies are able to match impressive targets in terms of cost after decades of process optimization. AM has just started to hit that point, while trying to expand beyond specific applications. Competitive AM processes are expected to come as raw material qualification, process experience, and new tech tools gain momentum. Design for AM, integrated supply chain capability, automation among production steps, and smart quality controls will play a critical role in cost reduction before brand new AM process adoption.

Brusco: What novel additive manufacturing and supporting capabilities do you expect to see for medical manufacturing in the near future?
Anderson: While advances in AM technology continue to evolve, the drive toward miniaturization in the medical device industry continues to outpace many of technology’s capabilities. We continue to develop partnerships with a multitude of medical device manufacturers, contract manufacturers, universities, startups, and others looking to produce high-resolution models in their engineering or biocompatible resin of choice, all increasingly pushing the envelope of micro-scale printing and production.

Another capability additive manufacturers will need to develop centers on both the expertise and technological capability to partner with customers to drive products through the value stream. Additive technology is widely used in R&D and product design, less so in short-run and bridge production and end-use manufacturing. Partnering with medical manufacturers to help them navigate that product lifecycle requires not only scalable additive manufacturing technology—including print preparation, management, and monitoring software, hardware, and post-processing—but also deep expertise in Lean manufacturing and value stream mapping, systems integration, the regulatory environment, and production.

The final capabilities we expect to see for medical manufacturing in the near future is customization. Many medical manufacturers have unique needs and applications, and we’ve partnered with an increasing number looking to pair our commercial additive manufacturing technology with custom hardware, software, materials, and services to equip them to deliver better products to market faster and cost-effectively.

Doyle: I expect to see better design and AM tools reduce the number of secondary processes. Better secondary operations include electropolishing and chemical etching. Also, surface treatment technology will add certain attributes: anti-microbial, bone growth, drug delivery, etc. New materials to replace existing ones which some folks reject will emerge. The biggest trend in medicine to affect AM will be personalization. For the patient, that means implants personalized to their body. For the surgeon, that means tools more customized to the procedure and/or for the surgeon. Other trends include pre-planning aids (digital (AR/VR) to physical), and lower cost polymer and composite implants.

Johnson: For applications, I expect to see more orthopedic patient-matched guides that help the surgeon prepare bony anatomy to receive a stock implant more quickly and effectively in the OR. Behind the scenes, there will be advances in software tools that help engineers and surgeons plan these cases more efficiently. For AM technology, the trend is toward hardware and material development that enables specific medical manufacturing use cases with production-ready, scalable solutions.

McLaughlin: In the near future, I expect to see growth in the adoption of AM for specific types of implants. The supply chain for AM is not great at the moment, so that could use some help.

Robotti: Software to help modeling and predictive performance analysis during device development are becoming more and more accurate as we gain insight in the process. Faster identification for the best support strategy, parts orientation, and heat conduction dispersion during building can leverage AI and machine learning tools capability. A great help will come from there to enable a “good at the first run” experience.

Article source:Medical Product Sourcing